Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051111

CD restriction and item codes

Do not share this attachment externally. See Freedom of Information - Information Publication Scheme.
$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.png$ PBS CD and FCD restriction and item codes

Calculator

$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-attachment.png$ Next assessment date (NAD) calculator

Contact details

PBS Complex Drugs Programs

Forms

Crohn's disease adult - initial authority application (PB087)

Crohn's disease adult - change, recommencement or demonstration of response authority application (PB235)

Crohn's disease adult - continuing authority application (PB088)

Crohn's disease paediatric - initial authority application (PB085)

Crohn's disease paediatric - change, recommencement or demonstration of response authority application (PB239)

Crohn’s disease paediatric - continuing authority application (PB161)

Fistulising Crohn's disease - initial or recommencement (treatment break greater than 5 years) authority application (PB092)

Fistulising Crohn’s disease - change, recommencement (treatment break less than 5 years) or demonstration of response authority application (PB236)

Fistulising Crohn's disease - continuing authority application (PB093)

Services Australia website

Crohn's disease - adult patient

Crohn's disease - paediatric patient

Crohn's disease - fistulising Crohn’s disease

External website

PBS schedule for Crohn's disease (adult patients)

PBS schedule for Crohn's disease (paediatric patients)

PBS schedule for Fistulising Crohn’s disease

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	The prescriber did not provide a CDAI at the baseline for an adult CD patient, but the patient is meeting CDAI now. Is this ok? No, a response can only be assessed against the parameters provided at baseline. There are 8 possible baseline targets for adult CD indicated on the database: CDAI ≤ 150 Normalisation of platelet count ESR ≤ 25mm/hr CRP ≤ 15mg/L Normalisation of lactoferrin or calprotectin level Evidence of mucosal healing on diagnostic imaging Reversal of high faecal output Prevention of surgery/TPN Note: if multiple parameters are provided at baseline, response only needs to be shown on one.
2	When a Paediatric CD patient turns 18, does the patient continue to be approved under the Paediatric CD item codes? No. They should be approved under adult CD item codes to meet age restriction criteria.
3	When a Paediatric CD patient turns 18 years, can a continuing adult CD application be submitted for them transferring from Paediatric CD? Yes. A continuing adult CD application should be provided. A change application form is not required, unless the prescriber wishes to change the patient’s biological medicine to an alternative one.
4	The prescriber provided a Paediatric CD application with a CDAI. Is this a rejection? No. The CDAI assessment with a Paediatric CD application form is acceptable.
5	The prescriber provided an adult CD application with a PCDAI. Is this a rejection? Yes. Not all responses can be answered on a PCDAI for an adult patient. An adult CDAI assessment must be provided if the patient is 18 years or older.
6	If the prescriber provides information about a change of baselines on a continuing application, how do you proceed? Escalate to a PA.
7	Can a patient with a baseline CDAI continue the same treatment using a fistula assessment? No. CD and FCD programs are separate. To change to either program, an initial application form must be submitted. Refer prescribers to the Services Australia website for initial application forms or a PA for enquiries.
8	Do all First Continuing requests need to complete 12 weeks of treatment? No. Some medications only require assessment of up to 12 weeks. See Process Tab Table 5 First Continuing Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS).
9	Does the change from intravenous (IV) form to subcutaneous (SC) form of the same medication require a change application or an escalation to a PA? No. A change of form type is not considered a change of medication and can be done as continuing or balance of supply without an escalation to a PA.
10	Is the extended induction required for upadacitinib before a first continuing can be approved? No. This is optional. If responding, the patient can be approved for first continuing directly after an initial, change or recommencement approval.
11	What is the maximum IV infliximab dose for Crohn’s and fistulising Crohn’s disease? The maximum PBS-subsidised dose that can be approved is 5mg/kg every 8 weeks after the initial loading dose.
12	Can the SC infliximab or vedolizumab be approved without IV treatment for an initial, change or recommencement request? No. SC treatment cannot be approved without a prior approval for an IV script.

Operational Information